Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments pf-06815345, placebo
Phase phase 1
Sponsor Pfizer
Start date November 2015
End date May 2016
Trial size 25 participants
Trial identifier NCT02654899, 2015-003935-36, C0281001

Summary

The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Experimental)
Single ascending dose of PF-06815345
pf-06815345
PF-06815345 will be administered as a liquid dosage formulation
(Placebo Comparator)
Single dose of placebo
placebo
Placebo
(Experimental)
Single ascending dose of PF-06815345
pf-06815345
PF-06815345 will be administered as a liquid dosage formulation
(Placebo Comparator)
Single dose of placebo
placebo
Placebo
(Experimental)
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
pf-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation

Primary Outcomes

Measure
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
time frame: Baseline (Day 0) up to 28 days after last dose of study medication

Secondary Outcomes

Measure
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06815345
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Healthy males and female of non-childbearing potential; - Age of 18-55, inclusive; - Body Mass Index 17.5-34.9 kg/m2, inclusive; - Body weight >50 kg; - Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose. Exclusion Criteria: - Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Additional Information

Official title A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf‑06815345 Administered To Healthy Adult Subjects
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Pfizer.